CRED ERP 25

Reflection paper on a tailored clinical approach in 13 biosimilar development 14

Table of contents

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16 1. Introduction ............................................................................................ 3 17 2. Scope....................................................................................................... 4 18 3. Discussion ............................................................................................... 4 19 3.1. Quality ................................................................................................................4 20 3.1.1. General basis and background.............................................................................4 21 3.1.2. Prerequisites for similarity assessment .................................................................4 22 3.1.3. Similarity assessment protocol ............................................................................6 23 3.1.4. Batches to be included in the similarity assessment ...............................................6 24 3.1.5. Analytical considerations ....................................................................................7 25 3.1.6. Assessment of physicochemical and functional similarity ........................................7 26 3.1.7. Uncertainties in the similarity assessment ............................................................9 27 3.1.8. Final reflection on Quality aspects...................................................................... 12 28 3.2. Clinical .............................................................................................................. 13 29 3.2.1. Utility and Limitations of Comparative Clinical Efficacy/Safety Trials....................... 13 30 3.2.2. The relevance of pharmacokinetic (PK) studies in biosimilar development............... 13 31 3.2.3. Pharmacodynamics (PD)................................................................................... 14 32 3.2.4. Safety and Immunogenicity .............................................................................. 15 33 3.3. Conclusion ......................................................................................................... 15 34 4. References ............................................................................................ 16 35 5. List of Abbreviations.............................................................................. 17

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Reflection paper on a tailored clinical approach in biosimilar development EMA/CHMP/BMWP/60916/2025

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